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RECRUITING Not applicable ClinicalTrials.gov

Remote Monitoring Using a Digital Platform

Sponsor: Hackensack Meridian Health • ClinicalTrials.gov ID: NCT07837102

Registry updated: 2026-09-23
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Description

A single site, proof-of-concept prospective behavioral interventional study testing remote monitoring among people living with chronic pain. The study is a single arm study. The duration of the study will be 12-18 months, enrolling 100 and following up to six months post enrollment/ baseline. A convenience sample of 50 patients with CP meeting the inclusion criteria will participate in a 3 to 6 month remote monitoring program utilizing FitCam. Since the time period to conduct this study is 12 months. FitCam portal/ app will be utilized for the intervention and the outcome will be recorded to observe if remote monitoring has an affect in the health outcome compared to baseline health quality of the patient.

Interventions

  • Remote application intervention (Behavioral)
    Participants will be assigned home exercise programs based on their primary pain location. The study team will provide verbal instructions to delineate the number of times a participant must log pain, mood, and sleep scores in the phone application and how to participate in the home exercise routines. Throughout the study, participants will be contacted by telephone call for a check-in visit.

Eligibility criteria

Inclusion Criteria: * Signed informed consent form (ICF) * Age: Adults aged 18 years or older * Ability to comply with the study protocol, including having a smartphone and being able and willing to access the application on a regular basis. To use all functionalities of the application, the user's smartphone must comply with the minimum system requirements (Android version 8.0 or above, iOS version 13.0 or above) * Have a valid email address * Have a valid phone number * Diagnosis Codes: * Patients with a confirmed diagnosis of Chronic Pain Syndrome based on ICD-10 code G89.4 as primary diagnosis. ■ Including Fibromyalgia M79.7 * Patient with a confirmed secondary diagnosis * Back Pain M54.5 * Neck Pain M54.2 * Joint Pain M25.5 * Medications: N/A * Test/Lab results: N/A * Study sites: Hackensack Meridian Health Neuroscience Institute located at 650 From Road, Suite 506, Paramus, NJ, 07652 * Service: Outpatient Exclusion Criteria: * Age: Patients below 18 years of age * Unable or unwilling to provide informed consent * Presence of an active diagnosis of a comorbid cognitive impairment such as dementia or mild cognitive impairment * Lack of access to a smartphone device or inability to demonstrate proficiency in downloading and using mobile applications * Physical limitations that prevent participation in a basic home exercise program * Considered by the investigator to have a condition that precludes safe or active participation in the trial

Conditions

Chronic Pain

Locations

  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Hackensack Meridian Health Neuroscience Institute — Paramus, New Jersey, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record